BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1202663 · Received October 21, 2008

    Report

    Report Number
    1034569-2008-00507
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT EXPIRED PRIOR THE RECEIVING THE COMPLAINT; NO SEROLOGICAL TESTING WAS PERFORMED. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING. THE INSTRUMENT IMAGES WERE REVIEWED. THE POSITIVE REACTION OBSEREVD BY THE CUSTOMER APPEARED VERY WEAK. MOST LIKELY, THE ANTIBODY IS AT THE LIMIT OF DETECTION. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY SCREEN 4 (CRRS) WHEN TESTING A PATIENT SAMPLE ON GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K173

    Patients

    Seq Age Sex Outcome Treatment
    1